Introducer for biopsy device

ABSTRACT

A biopsy system comprises an introducer, a biopsy device having a needle, and a marker applier. The introducer may include a closed distal tip, a lateral aperture, a proximally facing interior wall, and a ramp that guides the closed distal end of a marker applier up and into abutment with the wall as the applier is fed into the introducer. The needle of the biopsy device includes a blunt distal end and features providing clearance for the ramp as the blunt distal end is brought into abutment with the wall when the needle is fed into the introducer. The introducer may alternatively include an open distal end having resiliently biased leaves that bear against an inserted biopsy device needle. In some other versions, a fin projects laterally from the closed distal end of a marker applier, spacing the distal end away from a sidewall region of the introducer cannula.

BACKGROUND

Biopsy samples have been obtained in a variety of ways in variousmedical procedures using a variety of devices. Biopsy devices may beused under simple visual guidance, palpatory guidance, stereotacticguidance, ultrasound guidance, MRI guidance, PEM guidance, BSGIguidance, or otherwise. For instance, some biopsy devices may be fullyoperable by a user using a single hand, and with a single insertion, tocapture one or more biopsy samples from a patient. In addition, somebiopsy devices may be tethered to a vacuum module and/or control module,such as for communication of fluids (e.g., pressurized air, saline,atmospheric air, vacuum, etc.), for communication of power, and/or forcommunication of commands and the like. Other biopsy devices may befully or at least partially operable without being tethered or otherwiseconnected with another device.

Merely exemplary biopsy devices are disclosed in U.S. Pat. No.5,526,822, entitled “Method and Apparatus for Automated Biopsy andCollection of Soft Tissue,” issued Jun. 18, 1996; U.S. Pat. No.6,086,544, entitled “Control Apparatus for an Automated Surgical BiopsyDevice,” issued Jul. 11, 2000; U.S. Pub. No. 2003/0109803, entitled “MRICompatible Surgical Biopsy Device,” published Jun. 12, 2003; U.S. Pat.No. 7,507,210, entitled “Biopsy Cannula Adjustable Depth Stop,” issuedMar. 24, 2009; U.S. Pub. No. 2006/0074345, entitled “Biopsy Apparatusand Method,” published Apr. 6, 2006; U.S. Pub. No. 2007/0118048,entitled “Remote Thumbwheel for a Surgical Biopsy Device,” published May24, 2007; U.S. Pub. No. 2008/0214955, entitled “Presentation of BiopsySample by Biopsy Device,” published Sep. 4, 2008; U.S. Pub. No.2009/0171242, entitled “Clutch and Valving System for Tetherless BiopsyDevice,” published Jul. 2, 2009; U.S. Pub. No. 2010/0152610, entitled“Hand Actuated Tetherless Biopsy Device with Pistol Grip,” publishedJun. 17, 2010; U.S. Pub. No. 2010/0160819, entitled “Biopsy Device withCentral Thumbwheel,” published Jun. 24, 2010; U.S. Pub. No.2010/0317997, entitled “Tetherless Biopsy Device with Reusable Portion,”published Dec. 16, 2010; and U.S. Non-Provisional patent applicationSer. No. 12/953,715, entitled “Handheld Biopsy Device with NeedleFiring,” filed Nov. 24, 2010. The disclosure of each of the above-citedU.S. Patents, U.S. Patent Application Publications, and U.S.Non-Provisional Patent Applications is incorporated by reference herein.

In some settings, it may be desirable to mark the location of a biopsysite for future reference. For instance, one or more markers may bedeposited at a biopsy site before, during, or after a tissue sample istaken from the biopsy site. Exemplary marker deployment tools includethe MAMMOMARK™, MICROMARK®, and CORMARK™ brand devices from DevicorMedical Products, Inc. of Cincinnati, Ohio. Further exemplary devicesand methods for marking a biopsy site are disclosed in U.S. Pub. No.2009/0209854, entitled “Biopsy Method,” published Aug. 20, 2009; U.S.Pub. No. 2009/0270725, entitled “Devices Useful in Imaging,” publishedOct. 29, 2009; U.S. Pub. No. 2010/0049084, entitled “Biopsy MarkerDelivery Device,” published Feb. 25, 2010; U.S. Pub. No. 2011/0071423,entitled “Flexible Biopsy Marker Delivery Device,” published Mar. 24,2011; U.S. Pub. No. 2011/0071424, entitled “Biopsy Marker DeliveryDevice,” published Mar. 24, 2011; U.S. Pub. No. 2011/0071391, entitled“Biopsy Marker Delivery Device with Positioning Component,” publishedMar. 24, 2011; U.S. Pat. No. 6,228,055, entitled “Devices for Markingand Defining Particular Locations in Body Tissue,” issued May 8, 2001;U.S. Pat. No. 6,371,904, entitled “Subcutaneous Cavity Marking Deviceand Method,” issued Apr. 16, 2002; U.S. Pat. No. 6,993,375, entitled“Tissue Site Markers for In Vivo Imaging,” issued Jan. 31, 2006; U.S.Pat. No. 6,996,433, entitled “Imageable Biopsy Site Marker,” issued Feb.7, 2006; U.S. Pat. No. 7,044,957, entitled “Devices for Defining andMarking Tissue,” issued May 16, 2006; U.S. Pat. No. 7,047,063, entitled“Tissue Site Markers for In Vivo Imaging,” issued May 16, 2006; U.S.Pat. No. 7,229,417, entitled “Methods for Marking a Biopsy Site,” issuedJun. 12, 2007; and U.S. Pat. No. 7,465,279, entitled “Marker Device andMethod of Deploying a Cavity Marker Using a Surgical Biopsy Device,”issued Dec. 16, 2008. The disclosure of each of the above-cited U.S.Patents and U.S. Patent Application Publications is incorporated byreference herein.

While several systems and methods have been made and used for obtaininga biopsy sample, it is believed that no one prior to the inventors hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements. In thedrawings some components or portions of components are shown in phantomas depicted by broken lines.

FIG. 1A depicts a perspective view of an exemplary biopsy device and anexemplary introducer cannula, with the introducer cannula separated fromthe biopsy device;

FIG. 1B depicts a perspective view of the biopsy device and introducercannula of FIG. 1A, with the needle of the biopsy device inserted in theintroducer cannula;

FIG. 2A depicts a partial, side cross-sectional view of the introducercannula of FIG. 1A;

FIG. 2B depicts a partial, side cross-sectional view of the needle ofthe biopsy device and the introducer cannula of FIG. 1A, with the needleof the biopsy device inserted in the introducer cannula;

FIG. 3A depicts a partial, top cross-sectional view of latching featuresof the biopsy device and introducer cannula of FIG. 1A, with thelatching features uncoupled from each other;

FIG. 3B depicts a partial, top cross-sectional view of the latchingfeatures of FIG. 3A, with the latching features coupled with each other;

FIG. 4A depicts a perspective view of an exemplary biopsy site markerapplier, with the plunger of the marker applier in a proximal position;

FIG. 4B depicts a perspective view of the marker applier of FIG. 4A,with the plunger of the marker applier in a distal position to deploy amarker;

FIG. 5 depicts a perspective view of the marker applier of FIG. 4Ainserted in the introducer cannula of FIG. 1A, with the plunger of themarker applier in a distal position to deploy a marker;

FIG. 6 depicts a perspective view of an exemplary alternative distal endconfiguration for the needle of the biopsy device of FIG. 1A;

FIG. 7 depicts a perspective view of an exemplary alternative distal endconfiguration for the introducer cannula of FIG. 1A;

FIG. 8A depicts a partial, side cross-sectional view of the introducercannula of FIG. 7;

FIG. 8B depicts a partial, side cross-sectional view of the needle ofFIG. 6 inserted in the introducer cannula of FIG. 7;

FIG. 9 depicts a perspective view of an exemplary alternative distal endconfiguration for the marker applier of FIG. 4A;

FIG. 10 depicts a partial, side cross-sectional view of the markerapplier of FIG. 9;

FIG. 11 depicts a partial, side cross-sectional view of the markerapplier of FIG. 9 inserted in the introducer cannula of FIG. 7;

FIG. 12 depicts a perspective view of another exemplary alternativedistal end configuration for the needle of the biopsy device of FIG. 1A;

FIG. 13A depicts a partial, side cross-sectional view of anotherexemplary alternative distal end configuration for the introducercannula of FIG. 1A;

FIG. 13B depicts a partial, side cross-sectional view of the needle ofFIG. 12 inserted in the introducer cannula of FIG. 13A;

FIG. 14 depicts a perspective view of another exemplary alternativedistal end configuration for the marker applier of FIG. 4A;

FIG. 15 depicts a partial, side cross-sectional view of the markerapplier of FIG. 14 inserted in the introducer cannula of FIG. 13A;

FIG. 16 depicts a partial, side cross-sectional view of anotherexemplary marker applier disposed in a cutter within another exemplaryneedle;

FIG. 17 depicts a cross-sectional view of the marker applier, cutter,and needle of FIG. 16, taken along line 17-17 of FIG. 16;

FIG. 18 depicts a partial, side cross-sectional view of the markerapplier, cutter, and needle of FIG. 16, with the distal end of themarker applier positioned distal to the distal end of the cutter;

FIG. 19 depicts a cross-sectional view of the marker applier, cutter,and needle of FIG. 16, taken along line 19-19 of FIG. 18;

FIG. 20 depicts a perspective view of an exemplary alternative latchingfeature for an introducer; and

FIG. 21 depicts a side cross-sectional view of the latching feature ofFIG. 20.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Biopsy Device

FIGS. 1A-2B show an exemplary biopsy device (10). Biopsy device (10) ofthis example comprises a probe (30) and a holster (20). A needle (50)extends distally from probe (30), and is inserted into a patient'stissue to obtain tissue samples as will be described in greater detailbelow. These tissue samples are deposited in a tissue sample holder (40)at the proximal end of probe (30), as will also be described in greaterdetail below. Probe (30) is removably coupled with holster (20) in thepresent example. It should be understood that the use of the term“holster” herein should not be read as requiring any portion of probe(30) to be inserted into any portion of holster (20). A variety of typesof structures, components, features, etc. (e.g., bayonet mounts,latches, clamps, clips, snap fittings, etc.) may be used to provideremovable coupling of probe (30) and holster (20). Furthermore, in somebiopsy devices (10), probe (30) and holster (20) may be of unitary orintegral construction, such that the two components cannot be separated.By way of example only, in versions where probe (30) and holster (20)are provided as separable components, probe (30) may be provided as adisposable component, while holster (20) may be provided as a reusablecomponent. Still other suitable structural and functional relationshipsbetween probe (30) and holster (20) will be apparent to those ofordinary skill in the art in view of the teachings herein.

Needle (50) of the present example includes a cannula (52), a piercingtip (54), a lateral aperture (56) located proximal to tip (54), and ahub member (80). Tissue piercing tip (54) is configured to pierce andpenetrate tissue, without requiring a high amount of force, and withoutrequiring an opening to be pre-formed in the tissue prior to insertionof tip (54). Alternatively, tip (54) may be blunt (e.g., rounded, flat,etc.) if desired, including but not limited to having any of thealternative configurations described below. Tip (54) may also beconfigured to provide greater echogenicity than other portions of needle(50), providing enhanced visibility of tip (54) under ultrasoundimaging. By way of example only, tip (54) may be configured inaccordance with any of the teachings in U.S. Non-Provisional patentapplication Ser. No. 12/875,200, entitled “Echogenic Needle for BiopsyDevice,” filed Sep. 3, 2010, the disclosure of which is incorporated byreference herein. Other suitable configurations that may be used for tip(54) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

Lateral aperture (56) is sized to receive prolapsed tissue duringoperation of device (10). A hollow tubular cutter (70) having a sharpdistal edge (not shown) is located within a first lumen (60) of needle(50). Cutter (70) is operable to rotate and translate relative to needle(50) and past lateral aperture (56) to sever a tissue sample from tissueprotruding through lateral aperture (56). For instance, cutter (70) maybe moved from an extended position (FIG. 1) to a retracted position(FIG. 2B), thereby “opening” lateral aperture (56) to allow tissue toprotrude therethrough; then from the retracted position back to theextended position to sever the protruding tissue. Mechanical componentsin holster (20) and probe (30) may cooperate to provide such actuationof cutter (70), as described in any reference cited herein or otherwise.As another merely illustrative example, cutter (70) may be actuatedpneumatically in addition to or in lieu of being actuated by mechanicalcomponents. Other suitable alternative versions, features, components,configurations, and functionalities for providing cutter actuation willbe apparent to those of ordinary skill in the art in view of theteachings herein.

While lateral aperture (56) is shown oriented in an upward position inFIG. 1, it should be understood that needle (50) may be manually rotatedto orient lateral aperture (56) at any desired angular position aboutthe longitudinal axis of needle (50). Such rotation of needle (50) isfacilitated in the present example by hub member (80). Hub member (80)may be constructed and operable in accordance with the teachings of U.S.Non-Provisional patent application Ser. No. 12/953,715 and/or in anyother suitable fashion. Various other suitable ways in which manualrotation of needle (50) may be provided will be apparent to those ofordinary skill in the art in view of the teachings herein. It shouldalso be understood that rotation of needle (50) may be automated invarious ways, including but not limited to the various forms ofautomatic or mechanized needle rotation described in various referencesthat are cited herein.

As best seen in FIG. 2B, needle (50) also includes a longitudinal wall(64) extending proximally from the proximal portion of tip (54). Whilewall (64) does not extend along the full length of needle (50) in thisexample, it should be understood that wall (64) may extend the fulllength of needle (50) if desired. Wall (64) defines a second lumen (62)that is lateral to and parallel to cutter (70). Wall (64) includes aplurality of openings (66) that provide fluid communication betweensecond lumen (62) and first lumen (60), as well as fluid communicationbetween second lumen (62) and the lumen (not shown) of cutter (70). Forinstance, second lumen (62) may selectively provide atmospheric air tovent the lumen of cutter (70) during operation of biopsy device (10).Openings (66) are arranged such that at least one opening (68) islocated at a longitudinal position that is distal to the distal edge oflateral aperture (56). Thus, the lumen of cutter (70) and second lumen(62) may remain in fluid communication even when cutter (70) is advancedto a position where the distal cutting edge of cutter (70) is located ata longitudinal position that is distal to the longitudinal position ofthe distal edge of lateral aperture (56). Of course, as with any othercomponent described herein, any other suitable configurations may beused.

Probe (30) may also include a valve assembly in fluid communication withat least part of needle (50), selectively changing a pneumatic state ofat least part of needle (50) based on any suitable conditions such asthe longitudinal position of cutter (70). For instance, such a valveassembly may selectively change the pneumatic state of second lumen(62). Such a valve assembly may be constructed in accordance with theteachings of U.S. Pub. No. 2010/0317997; in accordance with theteachings of U.S. Non-Provisional patent application Ser. No.12/953,715; and/or otherwise. In addition or in the alternative, valvingmay be provided by a vacuum source and/or a vacuum canister, such as istaught in U.S. Pub. No. 2008/0214955. Other suitable alternativeversions, features, components, configurations, and functionalities ofneedle (50) will be apparent to those of ordinary skill in the art inview of the teachings herein.

Tissue sample holder (40) of the present example is configured toreceive tissue samples that are severed by cutter (70) and communicatedproximally through the hollow interior of cutter (70). Tissue sampleholder (40) may include one or more removable trays (not shown) thatpermit a user to remove severed tissue samples from tissue sample holder(40) without having to remove tissue sample holder (40) from probe (30).In some such versions, tissue sample holder (40) is constructed inaccordance with the teachings of U.S. Provisional Patent App. No.61/381,466, entitled “Biopsy Device Tissue Sample Holder with RemovableBasket,” filed Sep. 10, 2010, the disclosure of which is incorporated byreference herein. In addition or in the alternative, tissue sampleholder (130) may include a rotatable manifold (not shown) that is influid communication with a vacuum source and cutter (70); and that isrotatable to successively index separate tissue receiving chambers tocutter (70). By way of example only, tissue sample holder (40) may beconstructed and operable in accordance with the teachings of U.S. Pub.No. 2008/0214955, the disclosure of which is incorporated by referenceherein. As another merely illustrative example, tissue sample holder(40) may be constructed and operable in accordance with the teachings ofU.S. Pub. No. 2010/0160824, entitled “Biopsy Device with Discrete TissueChambers,” published Jun. 24, 2010, the disclosure of which isincorporated by reference herein. Still other suitable ways in whichtissue sample holder (40) may be constructed and operable will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Biopsy device (10) may also include a vacuum source (not shown), such asa vacuum pump. By way of example only, a vacuum source may beincorporated into probe (30), incorporated into holster (20), and/or bea separate component altogether. In versions where a vacuum source isseparate from probe (30) and holster (20), the vacuum source may becoupled with probe (30) and/or holster (20) via one or more conduitssuch as flexible tubing. It should also be understood that a vacuumsource may be in fluid communication with tissue sample holder (40) andneedle (50). Thus, the vacuum source may be activated to draw tissueinto lateral aperture (56) of needle (50). Tissue sample holder (40) isalso in fluid communication with cutter (70) in the present example. Avacuum source may thus also be activated to draw severed tissue samplesthrough the hollow interior of cutter (70) and into tissue sample holder(40). In some versions, a vacuum source is provided in accordance withthe teachings of U.S. Pub. No. 2008/0214955. In addition or in thealternative, a vacuum source may be provided in accordance with theteachings of U.S. Non-Provisional patent application Ser. No.12/953,715. As yet another merely illustrative example, a vacuum sourcemay be provided in accordance with the teachings of U.S. Non-Provisionalpatent application Ser. No. 12/709,695, entitled “Biopsy Device withAuxiliary Vacuum Source,” filed Feb. 22, 2010, the disclosure of whichis incorporated by reference herein. Still other suitable ways in whicha vacuum source may be provided will be apparent to those of ordinaryskill in the art in view of the teachings herein. It should also beunderstood that a vacuum source may simply be omitted, if desired.

Biopsy device (10) of the present example is sized and configured suchthat biopsy device (10) may be operated by a single hand of a user. Inparticular, a user may grasp biopsy device (10), insert needle (50) intoa patient's breast, and collect one or a plurality of tissue samplesfrom within the patient's breast, all with just using a single hand.Alternatively, a user may grasp biopsy device (10) with more than onehand and/or with any desired assistance. It should also be understoodthat biopsy device (10) may be configured to mount to a table orfixture, and be used under stereotactic guidance. Of course, biopsydevice (10) may instead be used under ultrasound guidance, MRI guidance,PEM guidance, BSGI guidance, or otherwise. In some settings, the usermay capture a plurality of tissue samples with just a single insertionof needle (50) into the patient's breast. Such tissue samples may bepneumatically deposited in tissue sample holder (40), and laterretrieved from tissue sample holder (40) for analysis. While examplesdescribed herein often refer to the acquisition of biopsy samples from apatient's breast, it should be understood that biopsy device (10) may beused in a variety of other procedures for a variety of other purposesand in a variety of other parts of a patient's anatomy (e.g., prostate,thyroid, etc.). Other suitable components, features, configurations, andoperabilities for biopsy device (10) will be apparent to those ofordinary skill in the art in view of the teachings herein.

II. Exemplary Introducer Cannula with Open Distal End

In some settings, needle (50) is inserted directly into a patient'stissue, such that the outer surface of the entire inserted length ofcannula (52) comes in direct contact with the patient's tissue. In someother versions, an introducer cannula is used. By way of example only,an introducer cannula having an open distal tip may first be insertedinto the patient's tissue. In some instances, an obturator having asharp distal tip (that protrudes from the open distal end of theintroducer cannula) may be disposed in the introducer cannula when thetwo are inserted into the patient's tissue. If an obturator is usedduring insertion into the patient's tissue, the obturator may be removedafter the introducer cannula has reached a desired depth in the tissue.Needle (50) and/or other instruments may then be fed into the introducercannula to reach the tissue at the distal end of the cannula.

In some settings, such as those where the needle of a biopsy device hasa sharp tip, the introducer may be coupled with the needle before thetwo are inserted together into the patient's tissue. A merelyillustrative example of this is shown in FIGS. 1A-2B. In particular,FIG. 1A shows biopsy device (10) and an exemplary introducer (100)before needle (50) of biopsy device (10) is inserted in introducer(100). FIG. 1B shows needle (50) inserted in introducer (100). As seenin FIGS. 1A-1B, introducer (100) of this example comprises a cannula(102), a pair of distal leaves (104) at an open distal end (106), and alatching feature (180). Latching feature (180) is operable toselectively secure introducer (100) to biopsy device (10) as will bedescribed in greater detail below. As seen in FIG. 2A, cannula (102)defines an internal lumen (112) that is in fluid communication with opendistal end (106). As also seen in FIG. 2A, leaves (104) are resilientlybiased to deflect slightly inwardly, yet a gap (110) is defined betweenleaves (104) to facilitate independent movement of leaves (104) towardor away from each other.

As best seen in FIGS. 1B and 2B, when cannula (52) of needle (50) isfully inserted into lumen (112) of cannula (102), a distal portion ofneedle (50) protrudes distally from cannula (102). In particular,lateral lumen (56) is fully exposed, being positioned distal to distaledges (108) of leaves (104). As can also be seen by comparing FIG. 2A(relaxed leaves (104)) to FIG. 2B (stressed leaves (104)), the outerdiameter of cannula (52) is greater than the inner diameter definedbetween relaxed leaves (104), such that cannula (52) deflects leaves(104) outwardly when cannula (52) is inserted in cannula (102). Inparticular, leaves (104) are deflected such that they are substantiallyaligned with proximal portions of the sidewall of cannula (102). Leaves(104) thus resiliently bear against cannula (52) of needle (50). In someversions, distal edges (108) of leaves (104) are chamfered, providing asubstantially smooth transition from the outer diameter of cannula (52)to the outer diameter of cannula (102).

In an exemplary use, introducer (100) is coupled with needle (50) asshown in FIGS. 1B and 2B. With cutter (70) at a distal position toeffectively close lateral aperture (56), introducer (100) and needle(50) are then inserted together into a patient's tissue. Tip (54)pierces and penetrates the patient's tissue during this insertion.Cutter (70) is then reciprocated to acquire one or more tissue samples,which are deposited into tissue sample holder (40) (e.g., using vacuumassistance, etc.). Once the desired number of tissue samples have beenacquired, needle (50) is decoupled from introducer (100), and cannula(52) is withdrawn from cannula (102), leaving cannula (102) disposed inthe patient's tissue. A marker applier may then be inserted into lumen(112) of cannula (102) to deposit one or more markers at the biopsysite. In addition or in the alternative, one or more medicaments,brachytherapy pellets, and/or other substances may be applied at thebiopsy site through lumen (112) of cannula (102). In addition or in thealternative, a variety of other kinds of instruments may be insertedthrough lumen (112) of cannula (102) to reach the biopsy site.Introducer (100) may then be pulled from the patient's tissue. Stillother suitable ways in which introducer (100) may be used will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Introducer (100) of the present example is operable to selectivelycouple with biopsy device (10) through a latching feature (180). As bestseen in FIGS. 3A-3B, latching feature (180) of this example comprises apair of latches (182) and associated buttons (184). Latches (182) arereceived in complementary slots (82) of hub member (80). Latches (182)include outward projections (186) that retain latches (182) in hubmember (80). Latches (182) and buttons (184) are positioned on resilientarms (188), which resiliently bias latches (182) to the positions shownin FIGS. 3A-3B yet allow latches (182) to be deflected inwardly toaccommodate insertion in slots (82) of hub member (80). Arms (188) alsoallow buttons (184) to be pressed inwardly toward each other to decouplelatches (182) from slots (82). As can also be seen in FIGS. 3A-3B, theinterior of latching feature (180) includes ramps (190) that help guidethe distal end of cannula (52) into lumen (112) of introducer (100).While not shown, it should be understood that introducer may include oneor more internal valves or seals, such as to reduce or prevent leakageof bodily fluids from introducer (100). It should also be understoodthat an introducer (100) may selectively couple with a biopsy device(10) in various other ways. Other suitable variations for latchingfeature (180) will be apparent to those of ordinary skill in the art inview of the teachings herein. Furthermore, introducer (100) need notnecessarily be securable to biopsy device (10), such that latchingfeature (180) and variations thereof may simply be omitted if desired.

As noted above, if needle (50) is withdrawn from introducer (100) withintroducer (100) remaining within the patient's tissue, introducer (100)may be used to guide a biopsy site marker applier instrument to thebiopsy site for deployment of one or more biopsy site markers. Forinstance, FIGS. 4A-4B show an exemplary marker applier (200) that may beused with introducer (100). Marker applier (200) of this examplecomprises a cannula (202) having an open distal end (204) with a sharptip (206). A biopsy site marker (210) is slidably disposed withincannula (202). A push rod (220) is also slidably disposed in cannula(202), and is operable to push marker (210) out through open distal end(204), as shown in FIG. 4B. A finger grip (222) and plunger (224) may bemanipulated by a single hand of a user to hold marker applier (200) andto advance push rod (220) distally for deployment of marker (210). Byway of example only, marker applier (200) comprises a CORMARK™ devicefrom Devicor Medical Products, Inc. of Cincinnati, Ohio in someversions.

As shown in FIG. 5, cannula (202) of marker applier (200) may beinserted through cannula (102) of introducer (100) to deploy marker(210) at a biopsy site after needle (50) of biopsy device (10) has beenwithdrawn from cannula (102) of introducer (100). As shown, the lengthsof cannulas (102, 202) are such that distal end (204) of marker applier(200) protrudes distally from distal end (106) of introducer (100). Itshould be understood that distal end (204) of marker applier (200) mayprotrude distally from distal end (106) of introducer (100) to anysuitable extent. In the present example, latching feature (180) does notcouple with any component of marker applier (200), though in some otherversions latching feature (180) may couple with a component of markerapplier (200). Still other suitable components, features,configurations, and relationships for introducer (100) and markerapplier (200) will be apparent to those of ordinary skill in the art inview of the teachings herein.

III. Exemplary Introducer Cannula with Closed Distal End and RampedProximal Inner Face

FIGS. 7-8B show an exemplary alternative needle (300) and introducer(400). It should be understood that needle (300) may be used instead ofneedle (50) for biopsy device (10). Similarly, it should be understoodthat introducer (400) may be used instead of introducer (100). Thus,proximal portions of needle (300) and introducer (400) may be configuredjust like proximal portions of needle (50) and introducer (100) asdescribed above. Furthermore, needle (300) and introducer (400) may beused just like the use of needle (50) and introducer (100) as describedabove. Of course, needle (300) and/or introducer (400) may have anyother suitable alternative configurations; and needle (300) and/orintroducer (400) may be used in various other suitable ways.

As shown in FIG. 6, needle (300) of the present example includes acannula (302) having a blunt closed distal end (304) and a lateralaperture (306) located proximal to closed distal end (304). A lowerchannel region (310) includes an open distal end (314). Open distal end(314) is located at a longitudinal position that is proximal to thelongitudinal position of closed distal end (304). As best seen in FIG.8B, cannula (302) defines a first lumen (308) that is configured toreceive a cutter (70). As can also be seen in FIG. 8B, a longitudinalwall (320) and a distal portion of lower channel region (310) define asecond lumen (322), which is lateral to and parallel to first lumen(308). While not shown, it should be understood that one or moreopenings may be formed in wall (320) to provide fluid communicationbetween second lumen (322) and first lumen (308).

As shown in FIGS. 7 and 8A, introducer (400) of this example comprises acannula (402), a piercing tip (404), and a lateral aperture (406)located proximal to tip (404). Tissue piercing tip (404) of this exampleis closed and is configured to pierce and penetrate tissue, withoutrequiring a high amount of force, and without requiring an opening to bepre-formed in the tissue prior to insertion of tip (404). Tip (404) mayalso be configured to provide greater echogenicity than other portionsof introducer (400), providing enhanced visibility of tip (404) underultrasound imaging. By way of example only, tip (404) may be configuredin accordance with any of the teachings in U.S. Non-Provisional patentapplication Ser. No. 12/875,200. Other suitable configurations that maybe used for tip (404) will be apparent to those of ordinary skill in theart in view of the teachings herein.

As best seen in FIGS. 8A-8B, introducer (400) further includes aproximally facing wall (410), a ramp (412), and a shelf (414) extendinglongitudinally from ramp (412) to wall (410). These features (410, 412,414) are just proximal to tip (404). As can also be seen in FIG. 8B,lateral apertures (306, 406) are substantially aligned when cannula(302) of needle (300) is inserted in cannula (402) of introducer (400).Furthermore, closed distal end (304) abuts proximally facing wall (410)and is positioned above shelf (414). Open distal end (314) of lowerchannel region (310) is positioned just proximal to ramp (412). In otherwords, the longitudinal position of distal end (314) relative to thelongitudinal position of distal end (304) provides clearance for ramp(412) and shelf (414) when cannula (302) of needle (300) is inserted incannula (402) of introducer (400) as shown in FIG. 8B. Furthermore, thevertical height of ramp (412) and the vertical height separating distalends (304, 314) are substantially similar, further facilitatingclearance for ramp (412) and shelf (414) when cannula (302) of needle(300) is inserted in cannula (402) of introducer (400).

In an exemplary use, introducer (400) is coupled with needle (300) asshown in FIG. 8B. With cutter (70) at a distal position to effectivelyclose lateral apertures (306, 406), introducer (400) and needle (300)are then inserted together into a patient's tissue. Tip (404) piercesand penetrates the patient's tissue during this insertion. Cutter (70)is then reciprocated to acquire one or more tissue samples, which aredeposited into tissue sample holder (40) (e.g., using vacuum assistance,etc.). Once the desired number of tissue samples have been acquired,needle (300) is decoupled from introducer (400), and cannula (302) iswithdrawn from cannula (402), leaving cannula (402) disposed in thepatient's tissue. A marker applier may then be inserted into cannula(402) to deposit one or more markers at the biopsy site. In addition orin the alternative, one or more medicaments, brachytherapy pellets,and/or other substances may be applied at the biopsy site throughcannula (402). In addition or in the alternative, a variety of otherkinds of instruments may be inserted through cannula (402) to reach thebiopsy site. Introducer (400) may then be pulled from the patient'stissue. Still other suitable ways in which introducer (400) may be usedwill be apparent to those of ordinary skill in the art in view of theteachings herein.

As noted above, if needle (300) is withdrawn from introducer (400) withintroducer (400) remaining within the patient's tissue, introducer (400)may be used to guide a biopsy site marker applier instrument to thebiopsy site for deployment of one or more biopsy site markers. Forinstance, FIGS. 9-11 show an exemplary marker applier (500) that may beused with introducer (400). Marker applier (500) of this examplecomprises a cannula (502) having a closed distal end (504) with a roundtip (506) and a lateral aperture (508) located proximal to tip (506).Marker applier (500) further includes a first ramp (510), a second ramp(512), and a shelf (514) extending longitudinally from ramp (510) toramp (512). Ramp (510) is configured to prevent a biopsy site marker(518) from inadvertently falling out through lateral aperture (508)prematurely. Ramp (512) leads to the distal end of lateral aperture(508) and is configured to guide marker (518) out through lateralaperture (508). In particular, a push rod (520) is slidably disposed incannula (502) and is operable to push marker (210) past ramp (510),along shelf (514), up ramp (512), and out through lateral aperture(508). Marker applier (500) may also include a finger grip and plunger(not shown) that may be manipulated by a single hand of a user to holdmarker applier (500) and to advance push rod (520) distally fordeployment of marker (518). By way of example only, marker applier (500)comprises a MAMMOMARK™ device from Devicor Medical Products, Inc. ofCincinnati, Ohio in some versions.

As shown in FIG. 11, cannula (502) of marker applier (500) may beinserted through cannula (402) of introducer (400) to deploy marker(518) at a biopsy site after needle (300) has been withdrawn fromcannula (402) of introducer (400). As shown, the length of cannulas(402, 502) is such that lateral apertures (406, 508) substantially alignwhen cannula (502) of marker applier (500) is inserted in cannula (402)of introducer (400). Furthermore, round tip (506) abuts proximallyfacing wall (410) and is positioned above shelf (414). Round tip (506)is thus trapped between shelf (414) and a distal-most part of thesidewall of cannula (402), distal to lateral aperture (406), such thatround tip (506) does not project from lateral aperture (406). As can beseen in FIG. 11, the inner diameter of cannula (402) is substantiallylarger than the outer diameter of cannula (502), such that a gap (420)is defined between the inner diameter of cannula (402) and the outerdiameter of cannula (502). It should therefore be understood that,during initial stages of insertion of cannula (502) of marker applier(500) in cannula (402) of introducer (400), cannula (502) may slidealong a lower region of cannula (402) until round tip (506) reaches ramp(412). Ramp (412) may then guide round tip (506) up to shelf (414) andthen to wall (410), thus raising distal end (504) of cannula (502). Thismay assist in properly aligning apertures (406, 508) and may otherwisefacilitate proper exit of marker (518) through lateral aperture (406) atthe biopsy site. It should also be understood that one or more spacers(not shown) may be positioned along the length of cannula (502) tosubstantially prevent buckling of cannula (502) within cannula (402),such as in some versions where cannula (502) is formed of a flexiblematerial. Still other suitable components, features, configurations, andrelationships for introducer (400) and marker applier (500) will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that, in some versions, cannula(502) may be fed through cutter (70) when cutter (70) is in a proximalposition and when needle (300) is still inserted in introducer (400),such that marker (518) may be deployed through all three apertures (306,406, 508).

IV. Exemplary Introducer Cannula with Closed Distal End and FlatProximal Inner Face

FIGS. 12-13B show another exemplary alternative needle (600) andintroducer (700). It should be understood that needle (600) may be usedinstead of needle (50) for biopsy device (10). Similarly, it should beunderstood that introducer (700) may be used instead of introducer(100). Thus, proximal portions of needle (600) and introducer (700) maybe configured just like proximal portions of needle (50) and introducer(100) as described above. Furthermore, needle (600) and introducer (700)may be used just like the use of needle (50) and introducer (100) asdescribed above. Of course, needle (600) and/or introducer (700) mayhave any other suitable alternative configurations; and needle (600)and/or introducer (700) may be used in various other suitable ways.

As shown in FIG. 12, needle (600) of the present example includes acannula (602) having a blunt closed distal end (604) and a lateralaperture (606) located proximal to closed distal end (604). As best seenin FIG. 13B, cannula (602) defines a first lumen (608) that isconfigured to receive a cutter (70). As can also be seen in FIG. 13B, alongitudinal wall (620) and a lower region of cannula (602) define asecond lumen (622), which is lateral to and parallel to first lumen(608). Wall (620) includes a plurality of openings (624) that providefluid communication between second lumen (622) and first lumen (608), aswell as fluid communication between second lumen (622) and the lumen(not shown) of cutter (70). Openings (624) are arranged such that atleast one opening (626) is located at a longitudinal position that isdistal to the distal edge of lateral aperture (606). Thus, the lumen ofcutter (70) and second lumen (622) may remain in fluid communicationeven when cutter (70) is advanced to a position where the distal cuttingedge of cutter (70) is located at a longitudinal position that is distalto the longitudinal position of the distal edge of lateral aperture(606). Of course, as with any other component described herein, anyother suitable configurations may be used.

As shown in FIGS. 13A-13B, introducer (700) of this example comprises acannula (702), a piercing tip (704), and a lateral aperture (706)located proximal to tip (704). Tissue piercing tip (704) of this exampleis closed and is configured to pierce and penetrate tissue, withoutrequiring a high amount of force, and without requiring an opening to bepre-formed in the tissue prior to insertion of tip (704). Tip (704) mayalso be configured to provide greater echogenicity than other portionsof introducer (700), providing enhanced visibility of tip (704) underultrasound imaging. By way of example only, tip (704) may be configuredin accordance with any of the teachings in U.S. Non-Provisional patentapplication Ser. No. 12/875,200. Other suitable configurations that maybe used for tip (704) will be apparent to those of ordinary skill in theart in view of the teachings herein. Introducer (700) of this examplefurther includes a proximally facing wall (710), just proximal to tip(704). As can also be seen in FIG. 8B, lateral apertures (606, 706) aresubstantially aligned when cannula (602) of needle (600) is inserted incannula (702) of introducer (700). Furthermore, closed distal end (604)abuts proximally facing wall (710).

In an exemplary use, introducer (700) is coupled with needle (600) asshown in FIG. 13B. With cutter (70) at a distal position to effectivelyclose lateral apertures (606, 706), introducer (700) and needle (600)are then inserted together into a patient's tissue. Tip (704) piercesand penetrates the patient's tissue during this insertion. Cutter (70)is then reciprocated to acquire one or more tissue samples, which aredeposited into tissue sample holder (40) (e.g., using vacuum assistance,etc.). Once the desired number of tissue samples have been acquired,needle (600) is decoupled from introducer (700), and cannula (602) iswithdrawn from cannula (702), leaving cannula (702) disposed in thepatient's tissue. A marker applier may then be inserted into cannula(702) to deposit one or more markers at the biopsy site. In addition orin the alternative, one or more medicaments, brachytherapy pellets,and/or other substances may be applied at the biopsy site throughcannula (702). In addition or in the alternative, a variety of otherkinds of instruments may be inserted through cannula (702) to reach thebiopsy site. Introducer (700) may then be pulled from the patient'stissue. Still other suitable ways in which introducer (700) may be usedwill be apparent to those of ordinary skill in the art in view of theteachings herein.

As noted above, if needle (600) is withdrawn from introducer (700) withintroducer (700) remaining within the patient's tissue, introducer (700)may be used to guide a biopsy site marker applier instrument to thebiopsy site for deployment of one or more biopsy site markers. Forinstance, FIGS. 14-15 show an exemplary marker applier (800) that may beused with introducer (700). Marker applier (800) of this example is verysimilar to marker applier (500) discussed above, except that markerapplier (800) includes an additional feature. Marker applier (800)comprises a cannula (802) having a closed distal end (804) with a roundtip (806) and a lateral aperture (808) located proximal to tip (806).Marker applier (800) further includes a first ramp (810), a second ramp(812), and a shelf (814) extending longitudinally from ramp (810) toramp (812). Ramp (810) is configured to prevent a biopsy site marker(not shown) from inadvertently falling out through lateral aperture(808) prematurely. Ramp (812) leads to the distal end of lateralaperture (808) and is configured to guide the marker out through lateralaperture (808). In particular, a push rod (not shown) is slidablydisposed in cannula (802) and is operable to push the marker past ramp(810), along shelf (814), up ramp (812), and out through lateralaperture (808). Marker applier (800) may also include a finger grip andplunger (not shown) that may be manipulated by a single hand of a userto hold marker applier (800) and to advance the push rod distally fordeployment of the marker. By way of example only, marker applier (800)comprises a modified MAMMOMARK™ device from Devicor Medical Products,Inc. of Cincinnati, Ohio in some versions.

One notable difference between marker applier (800) of this example andboth marker applier (500) described above and the MAMMOMARK™ device isthat marker applier (800) includes a transversely projecting fin (830)in this example. For instance, fin (830) may be molded as a unitaryfeature of tip (806) or may comprise a separate component that issecured to tip (806). Fin (830) is substantially rigid and does not moverelative to the rest of tip (806) in the present example, though itshould be understood that fin (830) may have other properties.

As shown in FIG. 15, cannula (802) of marker applier (800) may beinserted through cannula (702) of introducer (700) to deploy a marker ata biopsy site after needle (600) has been withdrawn from cannula (702)of introducer (700). As shown, the length of cannulas (702, 802) is suchthat lateral apertures (706, 808) substantially align when cannula (802)of marker applier (800) is inserted in cannula (702) of introducer(700). Furthermore, round tip (806) abuts proximally facing wall (710).As can be seen in FIG. 15, the inner diameter of cannula (702) issubstantially larger than the outer diameter of cannula (802), such thata gap (720) is defined between the inner diameter of cannula (702) andthe outer diameter of cannula (802). Nevertheless, fin (830) projectstransversely from tip (806) to a distance sufficient to keep distal end(804) raised up within cannula (702). This may assist in properlyaligning apertures (706, 808) and may otherwise facilitate proper exitof a marker through lateral apertures (706, 808) at the biopsy site. Itshould also be understood that one or more spacers (not shown) may bepositioned along the length of cannula (802) to substantially preventbuckling of cannula (802) within cannula (702), such as in some versionswhere cannula (802) is formed of a flexible material. Still othersuitable components, features, configurations, and relationships forintroducer (700) and marker applier (800) will be apparent to those ofordinary skill in the art in view of the teachings herein.

V. Exemplary Marker Applier with Tip Having Resilient Fin

FIGS. 16-19 show yet another exemplary needle (900) and marker applier(1000). In FIGS. 16-19, needle (900) is shown in cross-section whilemarker applier (1000) is not shown in cross-section. Cutter (970) isshown in cross-section in FIGS. 16 and 18. It should be understood thatneedle (900) may be used instead of needle (50) for biopsy device (10).Thus, the proximal portion of needle (900) may be configured just likethe proximal portion of needle (50) as described above. Needle (900) ofthis example includes a cannula (902), a piercing tip (904), and alateral aperture (906) located proximal to tip (904). Tissue piercingtip (904) of this example is closed and is configured to pierce andpenetrate tissue, without requiring a high amount of force, and withoutrequiring an opening to be pre-formed in the tissue prior to insertionof tip (904). Tip (904) may also be configured to provide greaterechogenicity than other portions of needle (900), providing enhancedvisibility of tip (904) under ultrasound imaging. By way of exampleonly, tip (904) may be configured in accordance with any of theteachings in U.S. Non-Provisional patent application Ser. No.12/875,200. Other suitable configurations that may be used for tip (904)will be apparent to those of ordinary skill in the art in view of theteachings herein.

Needle (900) also defines a lumen (910), in which a cutter (970) isdisposed. Lumen (910) distally terminates in a proximally facing wall(912), which is just proximal to tip (904). The difference between thediameter of lumen (910) and the outer diameter of cutter (970) is suchthat a substantial gap (914) exists between the exterior of cutter (970)and the interior surface of needle (900) that defines lumen (910). As inother examples described herein, cutter (970) reciprocates within needle(900) to sever a tissue sample from tissue protruding through lateralaperture (906). Gap (914) may serve as a second lumen of the typereferenced above, such that gap (914) may provide fluid communication tothe lumen (972) of cutter (970) (e.g., venting to atmosphere, etc.)during operation. Needle (900) is used without any kind of introducer inthis example, though it should be understood that needle (900) may beused with any suitable introducer (e.g., introducer (100), etc.), ifdesired.

Once cutter (970) has acquired a desired number of tissue samples,marker applier (1000) may be inserted through lumen (972) of cutter(970) and be used to deploy one or more biopsy site markers at thebiopsy site. Marker applier (1000) of the present example issubstantially similar to marker applier (800) described above. Inparticular, Marker applier (1000) comprises a cannula (1002) having aclosed distal end with a round tip (1006) and a lateral aperture (1008)located proximal to tip (1006). Marker applier (1000) further includes aramp (1012) that is configured to guide a marker out through lateralaperture (1008). In particular, a push rod (not shown) is slidablydisposed in cannula (1002) and is operable to push the marker along ramp(1012) and out through lateral aperture (1008). Marker applier (1000)may further include another ramp and a shelf, such as those describedabove. Marker applier (1000) may also include a finger grip and plunger(not shown) that may be manipulated by a single hand of a user to holdmarker applier (1000) and to advance the push rod distally fordeployment of the marker. Other suitable components, features, andconfigurations will be apparent to those of ordinary skill in the art inview of the teachings herein.

Marker applier (1000) of this example also includes a transverselyprojecting fin (1030). Fin (1030) is very similar to fin (830) describedabove, except that in this example fin (1030) is movable relative to therest of tip (1006). In some versions, fin (1030) is formed entirely orpartially of a resilient material that deforms yet is resiliently biasedto extend transversely from tip (1006). In addition or in thealternative, fin (1030) may be joined to tip (1006) by a living hinge orother similar feature. In some versions where a living hinge is used tojoin fin (1030) with tip (1006), the living hinge is resiliently biasedto urge fin (1030) to a transverse orientation relative to tip (1006).

In an exemplary use, with cutter (970) at a distal position toeffectively close lateral aperture (906), needle (900) is inserted intoa patient's tissue. Tip (904) pierces and penetrates the patient'stissue during this insertion. Cutter (970) is then reciprocated toacquire one or more tissue samples, which are deposited into tissuesample holder (40) (e.g., using vacuum assistance, etc.). Once thedesired number of tissue samples have been acquired, cutter (970) isretracted to a proximal position as shown in FIGS. 16-19, effectivelyopening lateral aperture (906). Marker applier (1000) is then feddistally through lumen (972) of cutter (970). As tip (1006) and fin(1030) travel through cutter (970), fin (1030) deforms and/or deflectsas shown in FIGS. 16-17. This is due to the inner diameter of cutter(970) being smaller than the outer diameter that is otherwisecollectively presented by tip (1006) and transversely extending fin(1030). As marker applier (1000) is fed further distally through cutter(970), tip (1006) and fin (1030) eventually clear the distal cuttingedge (974) of cutter (970). Upon clearing the restrictive inner diameterof cutter (970), the resilient bias of fin (1030) causes fin (1030) toproject transversely as shown in FIGS. 18-19. Marker applier (1000)continues to advance distally until tip (1006) abuts proximal face (912)of needle (900). At this stage, fin (1030) bears against the interior ofneedle (900) and thereby assists in keeping tip (1006) and lateralaperture (1008) raised up within cannula (902). This further assists inproperly aligning apertures (906, 1008), thereby facilitating properexit of a marker through lateral apertures (906, 1008) at the biopsysite. Still other suitable components, features, configurations, andoperabilities for marker applier (1000) will be apparent to those ofordinary skill in the art in view of the teachings herein.

VI. Exemplary Alternative Latching Feature

FIGS. 20-21 show an exemplary alternative latching feature (1180) thatmay be provided at the proximal end of cannula (102). It should beunderstood that latching feature (1180) is just one merely illustrativeexample of an alternative to latching feature (180) described above. Itshould also be understood that latching feature (1180) may be readilyincorporated into any introducer (100, 400, 700) described herein, amongvarious other types of structures into which latching feature (1180) maybe incorporated. Latching feature (1180) of this example includes a grip(1181) and a button (1184). A pair of latches (1182) extend from theproximal side of button (1184) and are unitary with button (1184).Latches (1182) include outward projections (1186) that are received incomplementary slots of hub member (80) to selectively retain latches(1182) in hub member (80). A coil spring (1188) is positioned betweenbutton (1184) and grip (1181), and resiliently biases button (1184) toan upward position. Coil spring (1188) nevertheless allows button (1184)to be pressed toward grip (1181), to correspondingly move latches(1182).

In an exemplary use, a user may insert cannula (52) into cannula (102)via latching feature (1180). A frustoconical ramp (1190) defined by grip(1181) helps guide the distal end of cannula (52) into cannula (102).When latches (1182) reach hub member (80), coil spring (1188) may becompressed to allow projections (1186) to move into engagement withcomplementary slots of hub member (80). Coil spring (1188) may thenexpand to hold projections (1186) in engagement with hub member (80)until button (1184) is later pressed to disengage projections (1186)from hub member (80). Still other suitable components, configurations,and operabilities that may be incorporated into a latching feature of anintroducer will be apparent to those of ordinary skill in the art inview of the teachings herein.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Embodiments of the present invention have application in conventionalendoscopic and open surgical instrumentation as well as application inrobotic-assisted surgery.

Embodiments of the devices disclosed herein can be designed to bedisposed of after a single use, or they can be designed to be usedmultiple times. Embodiments may, in either or both cases, bereconditioned for reuse after at least one use. Reconditioning mayinclude any combination of the steps of disassembly of the device,followed by cleaning or replacement of particular pieces, and subsequentreassembly. In particular, embodiments of the device may bedisassembled, and any number of the particular pieces or parts of thedevice may be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, embodiments of thedevice may be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device may utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

By way of example only, embodiments described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. A biopsy system, comprising: (a) a biopsy device having aneedle, wherein the needle includes a closed distal end having a sharptip, wherein the needle further includes a sidewall defining an outerperimeter, wherein the sidewall comprises two flat sides and two roundedsides, wherein the two flat sides and two rounded sides together definean oval shaped cross-section; and (b) an elongated introducer cannulahaving an open distal end, an open proximal end, and a sidewall, whereinthe sidewall includes a pair of opposing flat faces, and a pair ofopposing round faces, wherein the flat faces and round faces togetherdefine an oval shaped cross-section, wherein the elongated cannuladefines a longitudinal axis, wherein the distal end comprises aplurality of leaves, wherein the leaves are separated by a pair oflongitudinally extending gaps, wherein the leaves are resiliently biasedto deflect inwardly toward the longitudinal axis, wherein the leavesdefine an opening, wherein the leaves are configured to transitionbetween a stressed position and a relaxed position, wherein, in therelaxed position, the distal edges of the leaves are separated by a gapsuch that the distal end of the cannula remains open when the leaves arerelaxed, wherein an outer edge of each distal leaf extends along arespective axis when the leaves are in the relaxed position, wherein theleaves are configured to transition between the stressed and relaxedpositions by engagement with the outer perimeter of the sidewall of theneedle, wherein each gap of the pair of longitudinally extending gaps isdefined by the leaves to correspond with a respective flat face of theflat faces of the introducer cannula, wherein each flat face of theintroducer cannula is associated with a respective flat side of theneedle such that the longitudinally extending gaps align with the flatsides of the needle.
 2. The biopsy system of claim 1, wherein the needlefurther includes a lateral aperture formed proximal to the tip, whereinthe needle is insertable through the introducer cannula, wherein theneedle and the introducer cannula are sized such that the sharp tip andthe lateral aperture are positioned distal to the open distal end of theintroducer cannula when the needle is inserted in the introducercannula.
 3. The biopsy system of claim 2, wherein the biopsy device andthe introducer cannula comprise complementary latching featuresconfigured to selectively secure the introducer cannula to the biopsydevice.
 4. The biopsy system of claim 3, wherein the complementarylatching features comprise a slot and a resiliently biased latch memberinsertable in the slot.
 5. The biopsy system of claim 1, wherein theplurality of leaves comprises two leaves.
 6. The biopsy system of claim5, wherein one leaf extends distally further than the other leaf suchthat the distal end is at an angle relative to the longitudinal axis. 7.The biopsy system of claim 3, wherein the latching features comprise atleast one button, wherein the at least one button is resiliently biasedto actuate the latching features.
 8. The biopsy system of claim 2,further comprising a biopsy site marker applier, wherein the biopsy sitemarker applier comprises a cannula, wherein the cannula of the markerapplier is insertable through the introducer cannula of the introducer,wherein the biopsy site marker applier is operable to deploy a biopsysite marker at a biopsy site.
 9. The biopsy system of claim 8, whereinthe biopsy device, the biopsy site marker applier, and the introducercannula comprise complementary latching features configured toselectively secure the introducer cannula to the biopsy device, or thebiopsy site marker applier.
 10. The biopsy system of claim 1, whereinthe proximal end is tapered.
 11. A biopsy system, comprising: (a) anelongated introducer cannula having an open distal end and an openproximal end, wherein the elongated cannula defines a longitudinal axis,wherein the distal end comprises a pair of leaves, wherein the leavesare separated by a pair of longitudinally extending gaps, wherein eachgap of the pair of longitudinally extending gaps taper outwardly as eachgap extends from a distal end to a proximal end, wherein the leavesdefine an opening, wherein the leaves are movable between a stressedposition and a relaxed position, wherein the leaves are resilientlybiased to deflect inwardly toward the longitudinal axis when the leavesare in the relaxed position, wherein a distal edge of each leaf includesa chamfer; and (b) a biopsy device having a needle, wherein the needleincludes a needle cannula and a sharp tip disposed at a distal end ofthe needle cannula, wherein the needle cannula further includes alateral aperture formed proximal to the tip, wherein the needle isinsertable through the introducer cannula, wherein the needle and theintroducer cannula are sized such that the sharp tip and the lateralaperture are positioned distal to the open distal end of the introducercannula when the needle is inserted in the introducer cannula, whereinthe opening defined by the leaves of the introducer cannula has an innerperimeter when the leaves are in the relaxed position, wherein the innerperimeter is sized to permit the sharp tip of the needle to pass throughthe opening.
 12. A biopsy system, comprising (a) an elongated introducercannula having an open distal end and an open proximal end, wherein theelongated cannula defines a longitudinal axis, wherein the distal endcomprises a pair of leaves, wherein the leaves are separated by a pairof longitudinally extending gaps, wherein each gap of the pair oflongitudinally extending gaps includes a rounded proximal end, whereinthe leaves are resiliently biased to deflect inwardly toward thelongitudinal axis; and (b) a biopsy device having a needle, wherein theneedle includes a closed distal end having a sharp tip, wherein theneedle further includes a lateral aperture formed proximal to the tip,wherein the needle further comprises a sidewall defining an outerperimeter, wherein the needle is insertable through the introducercannula, wherein the needle and the introducer cannula are sized suchthat the sharp tip and the lateral aperture are positioned distal to theopen distal end of the introducer cannula when the needle is inserted inthe introducer cannula, wherein the biopsy device and the introducercannula comprise complementary latching features configured toselectively secure the introducer cannula to the biopsy device, whereinthe introducer cannula is configured to be inserted into a patient whenthe introducer cannula is attached to the biopsy device, wherein thebiopsy device is configured to be selectively removed from theintroducer cannula after the introducer cannula and biopsy device areinserted into the patient, wherein the opening defined by the leaves ofthe introducer cannula has an inner perimeter that is smaller relativeto the outer perimeter of the needle of the biopsy device such thatinsertion of the needle of the biopsy device into the introducer cannulacauses the leaves to resiliently bear against the sidewall of the needleof the biopsy device while the leaves are positioned away from the sharptip of the needle.